Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · May 18, 2021

Keywords

ClinConnect Summary

This clinical trial, called STICI-02, is looking at how well a combination of certain cancer treatments works when used together. Specifically, it focuses on using PD-1/PD-L1 inhibitors, which are drugs that help the immune system recognize and attack cancer cells, along with radiotherapy, a treatment that uses high-energy rays to kill cancer cells. The trial aims to find out if this combination is especially effective for patients with head and neck cancer, lung cancer, and other solid tumors. Additionally, the researchers want to understand how changes in immune cells in the blood can help predict who might benefit the most from this treatment.

To participate in this trial, you need to be at least 18 years old and have one of the eligible cancers, such as head and neck or lung cancer. You should also be suitable for treatment with a PD-1/PD-L1 inhibitor. The study is currently recruiting participants, and both men and women can take part. If you join the trial, you can expect to undergo various tests and treatments while the researchers collect information to better understand how these therapies work together and which patients they benefit the most. Please note that certain people, such as those with melanoma or those unable to follow the study guidelines, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or "other solid tumour"
• • Indication for system therapy with a PD-1/PD-L1 inhibitor according to clinical standards
• • Patients without or with radiation of one or more metastases
• • Age at least 18 years
• Exclusion Criteria:
• • Melanoma patients
• • Fertile patients who refuse effective contraception during study treatment
• • Persistent drug and/or alcohol abuse
• • Patients not able or willing to behave according to study protocol
• • Patients in care
• • Patients that are not able to speak German
• • Patients which are imprisoned according to legal or governmental order
• • Both gender are included into the study, a maximum age was not defined.